Apparatus, system, and method for neurostimulation by high frequency ultrasound

ABSTRACT

An apparatus, system, and method for neurostimulation by high frequency ultrasound. In one embodiment, an apparatus includes a pulse generator, an ultrasound transducer coupled to the pulse generator, and an implantable stimulator. The implantable stimulator may include a piezoelectric element configured to convert ultrasound signals from the ultrasound transducer into electrical signals, a rectifier configured to convert alternating current from the piezoelectric element to a monophasic current, a capacitor coupled to the rectifier, and a first electrode and a second electrode coupled to the rectifier and capacitor and configured to transmit the monophasic current to body tissue. In addition, the apparatus may include a current-limiting circuit configured to limit the amount of current transmitted to the body tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/402,632, filed Nov. 20, 2014, is a national phase application under35 U.S.C. § 371 of International

Application No. PCT/US2013/030812, filed Mar. 13, 2013, which claims thebenefit of U.S. Provisional Patent Application No. 61/650,082, filed May22, 2012, the contents of which applications are hereby incorporatedinto the present application by reference.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates to neurostimulation, and more particularlyrelates to an apparatus system and method for neurostimulation by highfrequency stimulation.

Description of the Related Art

Directly stimulating bioelectrically excitable tissue may be beneficialas a therapeutic tool. For example, neurostimulation may be used forrestoring function in cases of neural injury or disease.Neurostimulation as used herein refers to the stimulation ofelectrically excitable tissues of living things. This can include, forexample, the human tissues of the brain, heart, muscle, and nervoussystem.

Two methods of neurostimulation are the application of pulsed electricalcurrents directly to tissue through electrodes implanted within tissueand the indirect application of electrical currents through the bodysurface.

Directly applied electrical currents applied to tissue are known toaffect the membranes of excitable cells, causing a depolarizing effectthat can lead to a cell action event that depends on its type andbiological function. The pulsing of currents is sometimes needed toprevent accommodation to current flows and to fulfill certainphysiologic conditions that enables electricity to be effective. Directapplication of currents may have the disadvantage of requiring invasivetechniques, such as inserting probes or wires into the body.

It is also possible to apply electrical currents to the body surfacewhere they diffuse in the volume conductivity of tissue and attenuateaccording to well known laws. These currents can also stimulatenear-surface nerves and muscle tissues to some degree, but cannot reachdeeper tissues because of high electrical losses in tissue and the risein the needed current levels to above those that would cause electricalshock and tissue damage. It is also difficult to specifically stimulatea particular area of tissue without stimulating surrounding areas.

The strong diffusion of electrical current in tissues from surfaceelectrodes means that specific stimulation of a given nerve or nervefiber within a bundle is difficult. There is a tendency for electricalcurrents applied to the body surface to broadly stimulate in undesirableways. Implantable electrodes overcome these problems but are invasiveand suffer from the undesirable need to either run wires through theskin or work with relatively bulky implanted power systems that run onbatteries or are powered by external radiofrequency (RF) poweringtechniques.

SUMMARY OF THE INVENTION

An apparatus for neurostimulation is presented. In one embodiment, theapparatus includes a pulse generator, and an ultrasound transducercoupled to the pulse generator. In some embodiments, the apparatus mayinclude an implantable stimulator. The implantable stimulator mayinclude a piezoelectric element configured to convert ultrasound signalsfrom the ultrasound transducer into electrical signals, a rectifierconfigured to convert electrical signals from the piezoelectric element(which may be alternating current) to a monophasic current, and a firstelectrode and a second electrode coupled to the rectifier and configuredto transmit the monophasic current to body tissue. In some embodiments,the apparatus may include a current-limiting circuit configured to limitthe amount of current transmitted to the body tissue.

In some embodiments, the current-limiting circuit may be coupled to thefirst electrode and second electrode. In addition, the current-limitingcircuit may be a zener diode. In some embodiments, the implantablestimulator further comprises an electrical impedance matching circuitsuch as a voltage multiplier, charge pump. In some embodiments, thepiezoelectric element may comprise a series of elements that are wiredin a series or parallel configuration to adjust the output portimpedance. In some embodiments, the current-limiting circuit may includea pulse-width modulator configured to modulate a signal from the pulsegenerator to the ultrasound transducer. In addition, the pulse-widthmodulator may be configured to produce pulses with on-times between 1microsecond and 100 microseconds, and may be configured to producemodulated signals that have a duration between 50 microseconds and 500milliseconds.

In some embodiments, the current-limiting circuit may include a sensorconfigured to detect reporter signals on or near a skin surface. Inaddition, the current-limiting circuit may include a power-modificationcircuit configured to adjust the pulse generator in response to thereporter signals.

In some embodiments, the reporter signals may be electric signalsdetected by tissue volume conduction from the implant. In someembodiments, the reporter signals may be electromagnetic signalsdetected by an antenna placed on or in proximity to an implanted device.

The reporter signals may be used to determine when the neurostimulatoris in saturation.

A method for providing neurostimulation is also provided. In someembodiments, the method may include emitting a first electrical signalfrom a pulse generator. In addition, in some embodiments, the method mayinclude emitting an ultrasound signal from an ultrasound transducercoupled to the pulse generator. In some embodiments, the method mayinclude receiving the ultrasound signal in an implantable stimulator. Insome embodiments, the method may include converting the receivedultrasound signal to an electrical current. In addition, the method mayinclude limiting the current in a current-limiting circuit configured tolimit the amount of current transmitted to the body tissue. In someembodiments, the method may include conducting (flowing) the electricalcurrent to body tissue through the first electrode and second electrode.

In some embodiments, the method may include detecting reporter signalsproduced by the implantable stimulator on or near a skin surface. Inaddition, the method may include modulating the pulse generator inresponse to the reporter signals to adjust the amount of current flowedthrough the body tissue. In some embodiments, detecting the reportersignals may be performed with a loop antenna. In some embodiments,detecting the reporter signals may be performed with surface electrodeson the skin.

In some embodiments, the method may include determining a change instimulation current by detecting a change in the amplitude of thereporter signals. Furthermore, due to the acoustic transit time of anemitted ultrasound pulse detecting the reporter signal may be performedafter an end of the emitted ultrasound signal.

The term “coupled” is defined as connected, although not necessarilydirectly, and not necessarily mechanically.

The terms “a” and “an” are defined as one or more unless this disclosureexplicitly requires otherwise.

The term “substantially” and its variations are defined as being largelybut not necessarily wholly what is specified as understood by one ofordinary skill in the art, and in one non-limiting embodiment“substantially” refers to ranges within 10%, preferably within 5%, morepreferably within 1%, and most preferably within 0.5% of what isspecified.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a method ordevice that “comprises,” “has,” “includes” or “contains” one or moresteps or elements possesses those one or more steps or elements, but isnot limited to possessing only those one or more elements Likewise, astep of a method or an element of a device that “comprises,” “has,”“includes” or “contains” one or more features possesses those one ormore features, but is not limited to possessing only those one or morefeatures. For example, the method may include detecting reporter signalsonly during a calibration phase. However, in some embodiments, themethod may include constantly detecting reporter signals to adjust theoutput of the implantable neurostimulator. Furthermore, a device orstructure that is configured in a certain way is configured in at leastthat way, but may also be configured in ways that are not listed.

Other features and associated advantages will become apparent withreference to the following detailed description of specific embodimentsin connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings form part of the present specification and areincluded to further demonstrate certain aspects of the presentinvention. The invention may be better understood by reference to one ormore of these drawings in combination with the detailed description ofspecific embodiments presented herein.

FIG. 1 is a schematic block diagram illustrating one embodiment of animplantable neurostimulator.

FIG. 2 is a schematic block diagram of one embodiment of an implantableneurostimulator with feedback control.

FIG. 3 is a flow chart diagram depicting one embodiment of a method forproviding neurostimulation.

FIGS. 4-6 are graphical representations of neurostimulation simulationswith pulse width modulated signals.

FIGS. 7-8 are graphical representations of neurostimulation signals.

FIG. 9 shows one embodiment of the relationship between the output of apulse generator and a reporter signal from a neurostimulator.

DETAILED DESCRIPTION

Various features and advantageous details are explained more fully withreference to the non-limiting embodiments that are illustrated in theaccompanying drawings and detailed in the following description.Descriptions of well known starting materials, processing techniques,components, and equipment are omitted so as not to unnecessarily obscurethe invention in detail. It should be understood, however, that thedetailed description and the specific examples, while indicatingembodiments of the invention, are given by way of illustration only, andnot by way of limitation. Various substitutions, modifications,additions, and/or rearrangements within the spirit and/or scope of theunderlying inventive concept will become apparent to those skilled inthe art from this disclosure.

FIG. 1 illustrates one embodiment of a system 100 for neurostimulationby high frequency ultrasound. In one embodiment, the system 100 includesa pulse generator 102.

Coupled to the pulse generator 102 is an ultrasound transducer 104 thatcan convert electrical signals created by the pulse generator 102 intoultrasound signals 106. The ultrasound signals can vary in shape,duration, and length. For example, electrical signals from the pulsegenerator 102, and the corresponding ultrasound signals 106, may be atrain of pulses of a fixed or variable frequency, duty-cycle, andduration.

System 100 also includes an implantable stimulator 108. The implantablestimulator includes a piezoelectric element 110 that is configured toconvert ultrasound signals 106 from the ultrasound transducer 104 intoelectrical signals. The implantable stimulator 108 also includes arectifier 112 configured to convert alternating current from thepiezoelectric element 110, which is an alternating current, into amonophasic current. The rectifier may be a half-wave, or a full-waverectifier. For example, as shown in FIG. 1, four diodes 112 create afull-wave rectifier that converts the output of the piezoelectricelement 110 into a monophasic current.

System 100 includes a first electrode 116 and a second electrode 118coupled to the rectifier 112 and configured to transmit the monophasiccurrent to body tissue. The body tissue may be any body tissue in humansor animals. For example, the body tissue into which the monophasiccurrent is transmitted by the electrodes 116, and 118 may be part of thecentral or peripheral nervous system, or tissue associated with thosenervous systems. System 100 also includes a current-limiting circuitconfigured to limit the amount of current transmitted to the bodytissue. In this embodiment, the zener diode 114 is configured to limitthe maximum voltage that can be transmitted to the electrodes, andtherefore limit the current transmitted to the body tissue. Othercomponents that may limit the voltage transmitted to the electrodesinclude a PIN diode, a metal oxide varistor, avalanche conductiondiodes, as well as a system of components that may have an abruptcurrent conduction above a particular threshold voltage. The zener diode114 is coupled to the first electrode 116 by capacitor 120. In someembodiments, the capacitor may have a capacitance of about 1-10 μF. Insome embodiments, the capacitor 120 may be replaced by a chargebalancing circuit.

In some embodiments, the implantable stimulator 108 may include avoltage multiplier to increase the voltage delivered to the body tissue.The voltage multiplier may help match the impedance of the body tissueto control the amount of neurostimulation. For example, the voltagemultiplier may be a Cockroft-Walton multiplier that uses a series ofdiodes and capacitors to convert an AC voltage into a higher DC voltage.In addition, the voltage multiplier may include charge pumps orbuck-boost circuits, for example. In some embodiments, the outputcircuit is directly coupled to electrodes such that monophasic currentsflow in tissue. This may be desirable in certain electrical stimulationapplications such as where currents are applied to bone to promoteimproved osteogenesis. The high frequency monophasic current is smoothedto an average level by the capacitive nature of cell membranes and hasbeen found effective in stimulating tissue. At the electrode-tissueinterface there is a complex combination of resistive and capacitivenatures as well as a charge storage capability which responds to themonophasic current by acquiring the envelop of the monophasic pulsetrain. This presents a relatively lower frequency stimulation pulse tothe tissue that then responds as would a electrical pulse having theduration of the envelope of the pulse. This lower frequency monophasicpulse however needs to be compensated by a reverse low frequency currentflow in applications where net currents through electrodes produceundesired tissue reactions. Capacitive coupling of low frequencycurrents by an output coupling capacitor helps in the charge recovery.Electrical current flows through the tissue so as to inhibit the buildup of undesirable products of electrochemistry that emit from electrodeswhen currents are passed through them in body tissue. This capacitor maybe replaced by other methods of stimulating electrode charge balancingsuch as active circuits.

The current-limiting circuit may also include a pulse-width modulatorconfigured to modulate a signal from the pulse generator to theultrasound transducer. For example, electrical signals produced by thepulse generator 102 may be a train of pulses that vary in frequency,duty-cycle and/or duration. For example, the pulse generator 102 may beconfigured to produce pulses with on-times of 1 to 100 microseconds. Theultrasound transducer 104 may then convert those signals to ultrasoundsignals 106. In addition, pulse generator may be configured to producepulse-width modulated signals that have a duration of 50 microseconds to500 milliseconds. In addition, the frequency of the pulse widthmodulated signal can be varied. For example, if a signal has an on timeof 1 microsecond, a duty-cycle of 50%, and a duration of 1 millisecond,the output signal will include 500 pulses.

FIG. 2 illustrates a system 200 for neurostimulation. System 200includes the pulse generator 102, the ultrasound transducer 104, theultrasound signal 106, the piezoelectric element 110, the rectifier 112,the zener 114, capacitor 120, and electrodes 116 and 118 as described inconnection with FIG. 1. In addition, system 200 includes a sensor 204configured to detect signals 202 on or near a skin surface 210. Thesignals may be electrical signals or electromagnetic signals that can bedetected at the skin surface 210. The sensor 204 may be an electrodecoupled to the skin surface where the electrode is configured to detectelectric signals that travel through body tissue. In some embodiments,the sensor 204 may be configured to detect electromagnetic signals, orradio-frequency signals. For example, a loop antenna may be configuredto detect radiofrequency signals near the skin surface 210.

System 200 also includes a power-modification circuit 206 configured toadjust the pulse generator 102 in response to the detected signals 202.The feedback from the sensor 204 can be used to limit or increase theamount of current that is delivered to the body tissue.

The schematic flow chart diagrams that follow are generally set forth aslogical flow chart diagrams. As such, the depicted order and labeledsteps are indicative of one embodiment of the presented method. Othersteps and methods may be conceived that are equivalent in function,logic, or effect to one or more steps, or portions thereof, of theillustrated method. Additionally, the format and symbols employed areprovided to explain the logical steps of the method and are understoodnot to limit the scope of the method. Although various arrow types andline types may be employed in the flow chart diagrams, they areunderstood not to limit the scope of the corresponding method. Indeed,some arrows or other connectors may be used to indicate only the logicalflow of the method. For instance, an arrow may indicate a waiting ormonitoring period of unspecified duration between enumerated steps ofthe depicted method.

Additionally, the order in which a particular method occurs may or maynot strictly adhere to the order of the corresponding steps shown.

FIG. 3 illustrates a schematic flow diagram of a method for providingneurostimulation. In this embodiment, the method 300 begins by emitting302 a first electrical signal from a pulse generator. As described abovein connection with FIGS. 1 and 2, the signal from the pulse generatormay be modulated to vary in frequency, duty-cycle, and duration. Themethod also includes emitting 304 an ultrasound signal from anultrasound transducer coupled to the pulse generator. The ultrasoundtransducer 304 may be, for example, a piezoelectric ultrasoundtransducer.

Method 300 also includes the step of receiving 306 the ultrasound signalin an implantable stimulator, such as the implantable stimulatordescribed in connection with FIG. 1 above. In step 308, the methodconverts 308 the received ultrasound signal to an electrical current inthe implantable stimulator. In addition, the method includes the step oflimiting 310 the current in a current-limiting circuit. By limiting thecurrent, the amount of electrical stimulation delivered to the body canbe controlled. Limiting the current can create reproducible and safeneurostimulation while reducing unwanted effects of neurostimulation,such as providing too much current.

The step of limiting 310 the current in a current-limiting circuit mayinclude further steps for detecting how much current is produced by theimplantable neurostimulator. In some embodiments, a reporter signal maybe measured, where the reporter signal can be an electric signal, aradio frequency signal, or an acoustic signal emitted by the implantableneurostimulator. The acoustic signal is emitted by the neurostimulatorpiezoelectric elements as they resonate and have a prolonged ring-downafter being excited by the pulse generator. The amplitude of theacoustic response, since it is directly coupled to the limiting circuit,is modulated in the same way as the amplitude of electric signal.

In one embodiment, a reporter signal, a radiated radiofrequency emissionof the implanted neurostimulator 108, is used as an indication of theamount of current created by the neurostimulator. The radiofrequencysignal can be measured by a loop antenna. The sensor 104 is tuned to thesecond harmonic of the neurostimulator ultrasound signal 106 frequency.The harmonic emission from the neurostimulator may be distorted comparedto the ultrasound signal 106. For example, the distortion may be causedby the nonlinear behavior of the neurostimulator components, such as therectifier 112 or the zener diode 114. Although the second harmonic maybe stronger than other harmonics, and therefore be better suited fordetection, other harmonics may also be used to detect the amount ofcurrent delivered to the body tissue by the implanted neurostimulator.The amplitude of the response measured by the sensor 204 may indicatethat the implanted neurostimulator is in saturation. For example, whenthe voltage created by the piezoelectric element 110 and rectifier 112rises above the breakdown voltage of zener diode 114, theneurostimulator is operating in saturation. By ramping up the output ofthe pulse generator and measuring the point when the amplitude of theresponse reduces its rate of increase, the system can determine theintensity of the pulse generator's output required to place theimplantable neurostimulator in saturation. That power can then be usedfor deliver a known amount of voltage for neurostimulation. In someembodiments, the amplitude of the pulse generator can be increased by apredetermined amount (e.g. 20%) over what is necessary to place theneurostimulator in saturation to ensure that the neurostimulator reachessaturation with subsequent pulses. In some embodiments, the amplitude ofthe pulse generator can be decreased by a predetermined amount. Thenumber of subsequent pulses can then be used to vary the amount ofstimulation delivered by the neurostimulator.

In some embodiments, the reporter signal may be an electric signalemitted through the electrodes of the implantable neurostimulator. Theelectric signals may be detected using skin electrodes and used todetermine when the neurostimulator is in saturation.

In some embodiments, the acoustic transit time it takes an ultrasoundsignal to reach the neurostimulator can be used to separate theelectrical artifact signal generated by the pulse generator from thereceived radio frequency, such as the second harmonic. By separating thepulse generated by the pulse generator and the received radiofrequencysignal, noise from the pulse generator can be removed from the detectedradiofrequency signal. As such, the received signal can be measured withgreater accuracy to determine when the neurostimulator is in saturation.In some embodiments, the ultrasound transducer may be configured tosuppress harmonic artifact emissions to allow more accurate readings ofthe received radio frequency.

In some configurations with suitably short ultrasound pulses on theorder of 0.5 to 5 microseconds, the acoustic transit time delay of theemitted pulse can be used advantageously to separate the electricalartifact emitting from the ultrasound transducer from the detectedresponse monitored from body surface electrodes or an loop antenna. Inthis configuration the entire electrical evoked response from theneurostimulator regardless of its frequency components may be detectedand used for purposes of feedback controlling the power or determiningthe status if the implant. For example, the response may be used todetermine whether the stimulator is functional. This method isadvantageous in that such short ultrasound pulses are insufficient toevoke neurostimulation and so allow for a method of assessingneurostimulator currents that will flow with longer signal duration onthe order of 25 microseconds to 50 milliseconds without causingstimulation of the tissue. This allows for interrogation pulses toassess the neurostimulation current flow prior to emitting longersignals that will then appreciably stimulate tissue.

FIGS. 4-6 show results of simulations of neurostimulation provided by animplantable neurostimulator, such as that described above in connectionwith FIGS. 1 and 2. The signal 402 represents the output of the pulsegenerator 102 having a duty-cycle of about 90%. The signal 404represents the amount of current provided by the implantable stimulatorto simulated body tissue. As shown in FIG. 4, the stimulation current402 causes a pulse 404. Although signal 404 does show some ripplescaused by the individual pulses of signal 402, the simulated body tissueacts as a low-pass filter and results in a pulse of longer duration thatmay be more useful for neurostimulation.

FIG. 5 shows the same simulation as shown in FIG. 4, but the pulses insignal 502 have a lower duty cycle, around 50%, than the pulses insignal 402. The resulting output current 504 shows a reduced amplitudeas compared to current 404. By modifying the duty-cycle of thestimulating signals 402 and 502, the amplitude of the signals 404 and504 delivered to the simulated body tissue can be controlled. FIG. 6shows the results of a similar simulation, where the stimulating signal602 has a duty-cycle of about 10% and causes the output current 604 tobe reduced in amplitude compared to output currents 404 and 504.

FIGS. 7 and 8 show an example of how the zener diode 114 in FIG. 1 canlimit the output voltage, and as a result, the output current of theimplantable neurostimulator. Signal 702 in FIG. 7 represents the outputof the pulse generator 102. Signal 802 shows the output of the full-waverectifier created by diodes 112. Finally, output signal 804 shows theeffect of the zener diode 114. When the signal 802 rises above thebreakdown voltage of zener diode 114, the implantable neurostimulatoroutput signal is limited to that voltage. As such, the output voltage,and concomitant current used for neurostimulation is limited.

FIG. 9 shows an example of the relationship between the output of thepulse generator and the reporter signal emitted by the neurostimulator.In this example, the x-axis 902 represents time, and the y-axisrepresents amplitude. Signal 906 represents the output of the pulsegenerator—the output increases over time. As the pulse generator output,and the corresponding ultrasound output increase, the current deliveredto the body tissue also increases. As the current delivered to the bodytissue increases, the reporter signal 908 also increases. However, whenthe neurostimulator reaches saturation, the amount of current deliveredto the body tissue will plateau at 910. The output of the pulsegenerator may continue to increase, but the reporter signal does not.

All of the methods disclosed and claimed herein can be made and executedwithout undue experimentation in light of the present disclosure. Whilethe apparatus and methods of this invention have been described in termsof preferred embodiments, it will be apparent to those of skill in theart that variations may be applied to the methods and in the steps or inthe sequence of steps of the method described herein without departingfrom the concept, spirit and scope of the invention. In addition,modifications may be made to the disclosed apparatus and components maybe eliminated or substituted for the components described herein wherethe same or similar results would be achieved. All such similarsubstitutes and modifications apparent to those skilled in the art aredeemed to be within the spirit, scope, and concept of the invention asdefined by the appended claims.

1.-20. (canceled)
 21. A neurostimulation system with feedback controlcomprising: a variable electrical signal pulse-generator; a sensorconfigured to detect subcutaneous electromagnetic signals from asubcutaneous implant not physically connected to the sensor and notphysically connected to the variable electrical signal pulse-generator;a power modification circuit configured to adjust signals beinggenerated by the variable electrical signal pulse-generator in responseto the subcutaneous electromagnetic signals detected by the sensor,wherein the signal adjustment of the power modification circuit includesmodulating the variable electrical signal pulse-generator in response tothe detected electromagnetic signals to adjust the amount of currentflowed through the body tissue from the subcutaneous implant.
 22. Theneurostimulation system of claim 21 wherein the pulse generator isconfigured to generate a train of fixed frequency pulses and a train ofvariable frequency pulses.
 23. The neurostimulation system of claim 21wherein the pulse generator is configured to generate a train of fixedduty-cycle pulses and a train of variable duty cycle pulses.
 24. Theneurostimulation system of claim 21 wherein the pulse generator isconfigured to generate a train of fixed duration pulses and a train ofvariable duration pulses.
 25. The neurostimulation system of claim 21wherein the implant is configured to convert alternating current into amonophasic current and further configured to discharge the monophasiccurrent into tissue within a body of a patient through an electrode. 26.The neurostimulation system of claim 25 wherein the biocompatibleimplant further comprises a voltage limiting zenner diode, the diodeelectrically coupled to a capacitor, the capacitor electrically coupledto the electrode.
 27. The neurostimulation system of claim 21 whereinthe sensor comprises a loop antenna.
 28. A neurostimulation system withfeedback control comprising: a variable electrical signalpulse-generator; a sensor configured to detect subcutaneouselectromagnetic signals from a subcutaneous implant not physicallyconnected to the sensor and not physically connected to the variableelectrical signal pulse-generator; a power modification circuitconfigured to adjust signals being generated by the variable electricalsignal pulse-generator in response to the subcutaneous electromagneticsignals detected by the sensor, wherein the signal adjustment of thepower modification circuit includes modulating the variable electricalsignal pulse-generator in response to the detected electromagneticsignals to adjust the amount of current flowed through the body tissuefrom the subcutaneous implant, and wherein the sensor is furtherconfigured to measure an amplitude of the detected electromagneticsignals and is used to determine if the subcutaneous implant isoperating in a saturation state.
 29. The neurostimulation system ofclaim 28 wherein the pulse generator is configured to generate a trainof fixed frequency pulses and a train of variable frequency pulses. 30.The neurostimulation system of claim 28 wherein the pulse generator isconfigured to generate a train of fixed duty-cycle pulses and a train ofvariable duty cycle pulses.
 31. The neurostimulation system of claim 28wherein the pulse generator is configured to generate a train of fixedduration pulses and a train of variable duration pulses.
 32. Theneurostimulation system of claim 28 wherein the implant is configured toconvert alternating current into a monophasic current and furtherconfigured to discharge the monophasic current into tissue within a bodyof a patient through an electrode.
 33. The neurostimulation system ofclaim 32 wherein the biocompatible implant further comprises a voltagelimiting zenner diode, the diode electrically coupled to a capacitor,the capacitor electrically coupled to the electrode.
 34. Theneurostimulation system of claim 28 wherein the sensor comprises a loopantenna.
 35. A neurostimulation system with feedback control comprising:a variable electrical signal pulse-generator; a sensor configured todetect subcutaneous electromagnetic signals from a subcutaneous implantnot physically connected to the sensor and not physically connected tothe variable electrical signal pulse-generator; a power modificationcircuit configured to adjust signals being generated by the variableelectrical signal pulse-generator in response to the subcutaneouselectromagnetic signals detected by the sensor, wherein the signaladjustment of the power modification circuit includes modulating thevariable electrical signal pulse-generator in response to the detectedelectromagnetic signals to adjust the amount of current flowed throughthe body tissue from the subcutaneous implant, wherein the sensor isconfigured to measure an amplitude of the detected electromagneticsignals and is used to determine if the subcutaneous implant isoperating in a saturation state, and wherein the power modificationcircuit is configured to measure a point where the amplitude of thedetected electromagnetic signal reduces its rate of increase and thendetermine the intensity of output of the variable electrical signalpulse-generator required to place the subcutaneous implant insaturation.
 36. The neurostimulation system of claim 35 wherein thepulse generator is configured to generate a train of fixed frequencypulses and a train of variable frequency pulses.
 37. Theneurostimulation system of claim 35 wherein the pulse generator isconfigured to generate a train of fixed duty-cycle pulses and a train ofvariable duty cycle pulses.
 38. The neurostimulation system of claim 35wherein the pulse generator is configured to generate a train of fixedduration pulses and a train of variable duration pulses.
 39. Theneurostimulation system of claim 35 wherein the implant is configured toconvert alternating current into a monophasic current and furtherconfigured to discharge the monophasic current into tissue within a bodyof a patient through an electrode.
 40. The neurostimulation system ofclaim 39 wherein the biocompatible implant further comprises a voltagelimiting zenner diode, the diode electrically coupled to a capacitor,the capacitor electrically coupled to the electrode.